What are the advantages and disadvantages of incorporating a Smartphone into a Medical Device?
Just as advances in the electronics industry have enabled trends in medical diagnostics towards point-of-care devices, wearables and home monitoring, the Smartphone is giving rise to an increasing number of connected devices providing remote monitoring in telemedicine and personalised care.
Why might I include a Smartphone?
As the global trend towards data harvesting and big data analysis gathers momentum, the uses of data for anthropomorphic and geographic trending contributes to our continued understanding of disease and patient behaviour. Furthermore, the growth of personalised medicine, with tailored diagnostics and solutions, can be facilitated by individual communications interfaces.
Smartphones provide a powerful resource for diagnostic products, with built-in processing power, user interface and wireless connectivity all packaged into a convenient, portable product. The processing power is sufficient to process data into reportable results, even if the data acquisition must be achieved using a separate device. The advantages are obvious; cost, size, familiar user interface, remote monitoring etc.
Smartphones increasingly include rapidly-improving technologies that can be used as the primary data acquisition tool. Take CFT’s microcapillary technology for instance, which can be read using the capabilities of a Smartphone camera. Spirocall and ResApp both use over-the-phone analysis of breath sounds to diagnose respiratory functionality.
Why should I think twice before incorporating a Smartphone?
A Smartphone is only relevant when the target market for the diagnostic includes users (patients or healthcare workers) with access to a Smartphone and where there is reliable provision of 3rd party connectivity services. Furthermore, there are concerns around security and privacy. Over 750,000 smartphones get stolen in the UK every year. Applications that transfer Protected Healthcare Information (PHI) to, or share data with, healthcare providers must be HIPAA compliant in the USA. However, the EU is still in the process of realising the General Data Protection Regulation (GDPR).
The clinical sensitivity of a Smartphone medical device can be limited by the on-board hardware. Image capture is limited to visible spectrum data and the accuracy of gyroscopic or sound input data is determined by the user’s preferred model of Smartphone rather than the desired requirements of the medical device. It’s important to be sure that the Smartphone offers sufficient capability for the market, even if this isn’t the optimum that the diagnostic system is capable of.
The choice of Smartphone will be governed by the target market and the operating system selection will have knock-on effects both in development and post-launch support. If a device is stand-alone, it is immune from updates to a Smartphone’s operating system and won’t require 3rd party authorisation of an App, the costs and timescales of which vary between providers (Windows, Android, iOS). If the Smartphone doesn’t offer enough advantages, it may be more cost effective to make the device stand-alone.
What is the impact on development?
Incorporating a Smartphone means there is already a vision of what the final product might look like. To some extent, the developmental end point is determined and there may be fewer variables within the development process. Alternatively, pre-determining the inclusion of the Smartphone might limit the potential of a technology. A decision to use a Smartphone requires decisions about operating systems and applications early in the development cycle. It may eliminate some of the hardware development steps in the process but introduces additional software development activities, including verification by Apple/Microsoft/Google, with the associated timescales and fees. Whilst the use of a Smartphone may reduce timescales to the production of a prototype or demonstrator, App authorisation and the on-going support costs associated with supporting the latest smartphones and operating system releases will almost certainly increase costs and timescales later in the process.
Are there regulatory issues?
Aside from the data protection issues, any device that is only a Smartphone + App may be viewed as a class II device by the MHRA. If in doubt, seek advice early in the development process.
Is this a helpful trend for Healthcare workers?
It’s hard to resist the allure of the Smartphone medical device. The challenge will be arming Healthcare providers with the tools to manage the data provided and enabling them to use this in a time and cost-efficient way. Using a Smartphone should provide some benefit derived from earlier diagnosis, reduced hands-on care time or de-skilled diagnosis, and not just increased data generation.
For help incorporating a Smartphone into a Medical Device development contact eg technology Ltd.